RAMIPRIL NORMON 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril Normon 10 mg Tablets EFG

Ramipril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Ramipril Normon and what is it used for
2. What you need to know before you take Ramipril Normon
3. How to take Ramipril Normon
4. Possible side effects
5. Storing Ramipril Normon
6. Contents of the pack and other information

1. What is Ramipril Normon and what is it used for

Ramipril Normon contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Ramipril Normon works by:

• Reducing the production of substances in your body that could increase your blood pressure.
• Relaxing and widening your blood vessels.
• Making it easier for your heart to pump blood around your body.

Ramipril Normon can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of you having a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether you have diabetes or not).
• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure).
• As a treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before you take Ramipril Normon

Do not take Ramipril Normon

• If you are allergic to ramipril, any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6).

The symptoms of an allergic reaction can include rash, difficulty swallowing or breathing, swelling of your face, lips, throat or tongue.

• If you have ever had a serious allergic reaction called “angioedema”. The symptoms include itching, rash, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are having dialysis or any other type of blood filtration. Depending on the machine used, Ramipril Normon may not be suitable for you.
• If you have kidney artery stenosis (narrowing of the artery supplying blood to your kidneys).
• During the last 6 months of pregnancy (see section “Pregnancy and breast-feeding” below).
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• If you have diabetes or kidney problems and are treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Ramipril Normon if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril Normon.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril Normon:

• tell your doctor if you are pregnant (or think you might be). Ramipril Normon is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breast-feeding” below).
• • an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril Normon”.

Children and adolescents

The use of Ramipril Normon in children and adolescents under 18 years is not recommended because the safety and efficacy of Ramipril Normon in children have not yet been established.

If any of the above applies to you (or if you are not sure), talk to your doctor before taking Ramipril Normon.

Using Ramipril Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ramipril Normon may affect the way other medicines work. Also, some medicines may affect the way Ramipril Normon works.

Tell your doctor if you have taken or are taking any of the following medicines, which may make Ramipril Normon work less well:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These may increase the risk of side effects if taken with Ramipril Normon:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Normon”).
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin).
• Cancer medicines (chemotherapy)
• Medicines to prevent organ rejection after a transplant, such as cyclosporin.
• Diuretics, such as furosemide.
• Medicines that may increase the amount of potassium in your blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to make your blood more fluid)
• Corticosteroids for inflammation, such as prednisolone.
• Allopurinol (used to reduce uric acid in your blood)

• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).

• Racecadotril (used for diarrhea).
• Your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Ramipril Normon” and “Warnings and precautions”)

Tell your doctor if you are taking any of the following medicines. These may be affected by Ramipril Normon:

• Medicines for diabetes, such as oral medicines to lower blood sugar and insulin. Ramipril Normon may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril Normon.
• Lithium (for mental health problems). Ramipril Normon may increase the level of lithium in your blood. Your doctor will closely monitor your lithium levels.

If any of the above applies to you (or if you are not sure), talk to your doctor before taking Ramipril Normon.

Taking Ramipril Normon with food and drink

• Drinking alcohol with Ramipril Normon may make you feel dizzy or faint. If you are worried about how much you can drink while taking Ramipril Normon, talk to your doctor, as blood pressure-lowering medicines and alcohol can have additive effects.
• Ramipril Normon can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Tell your doctor if you are pregnant (or think you might be).

Do not take Ramipril Normon during the first 12 weeks of pregnancy and do not take it at all after the 13th week, as it may cause serious harm to your baby. If you become pregnant while taking Ramipril Normon, tell your doctor immediately. You should switch to a different treatment before you become pregnant.

Breast-feeding

Do not take Ramipril Normon if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy while taking Ramipril Normon, which is more likely to happen when you start taking Ramipril Normon or start taking a higher dose of Ramipril Normon. If this happens, do not drive or use tools or machines.

Ramipril Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ramipril Normon

Take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

How much to take

Treating high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you take to control your blood pressure.
• The maximum daily dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may stop or reduce the diuretic you were taking before starting Ramipril Normon.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the amount you take.
• The usual dose is 10 mg once a day.

Treating kidney problems

• You can start with a dose of 1.25 mg or 2.5 mg once a day.

Your doctor will adjust the amount you are taking.

• The usual dose is 5 mg or 10 mg once a day.

Treating heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you are taking.
• The maximum daily dose is 10 mg once a day. It is best taken twice a day.

Treating after a heart attack

• The usual starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 10 mg once a day. It is best taken twice a day.

Elderly patients

Your doctor will lower the initial dose and adjust your treatment more slowly.

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Swallow the Ramipril Normon tablets whole, with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril Normon than you should

See a doctor immediately or go to the casualty department of your nearest hospital. Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you. This will help your doctor know what you have taken.

You can also contact the National Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Ramipril Normon

• If you forget to take a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Ramipril Normon and go to a doctor immediately if you notice any of the following serious adverse effects - you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can make it difficult to swallow or breathe, as well as itching and hives. This can be a symptom of a severe allergic reaction to Ramipril Normon.
• Severe skin reactions, including rash, ulcers in your mouth, worsening of a pre-existing skin condition, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme)

Tell your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or coughing. These can be symptoms of lung problems.
• Easy bruising, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, or getting infections more easily than normal, sore throat, and fever, feeling tired, dizzy, or pale skin. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can radiate to your back. This can be a symptom of acute pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (vomiting), yellowing of the skin or eyes (jaundice). These can be symptoms of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other adverse effects include:

Tell your doctor if any of the following symptoms worsen or last more than a few days.

Frequent(may affect up to 1 in 10 patients)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when you start taking Ramipril Normon or when you start taking a higher dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or feeling quickly.
• Dry, irritating cough, inflammation of your nasal passages (sinusitis) or bronchitis, shortness of breath.
• Stomach pain or abdominal pain, diarrhea, indigestion, feeling sick.
• Rash on the skin, with or without raised areas.
• Chest pain.
• Cramps or muscle pain.
• Blood tests showing higher than normal potassium levels in your blood.

Infrequent(may affect up to 1 in 100 patients)

• Balance problems (vertigo).
• Itching and abnormal sensations on the skin, such as numbness, tingling, pinching, burning, or chilliness on your skin (paresthesia).
• Loss or changes in the taste of things.
• Sleep problems.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• A swelling in your abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Urinating more than usual during the day.
• Sweating more than usual.
• Loss or decreased appetite (anorexia).
• Increased or irregular heartbeats. Swelling of arms and legs. This can be a sign that your body is retaining more water than normal.
• Redness.
• Blurred vision.
• Pain in your joints.
• Fever.
• Sexual dysfunction in men, decreased sexual desire in men or women.
• Increased number of certain white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in the way your liver, pancreas, or kidneys are functioning.

Rare(may affect up to 1 in 1,000 patients)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe scaling or peeling of the skin, rash, swelling, itching.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Rash or bruising on the skin.
• Redness on your skin and cold extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Hearing disturbances and noises in your ears.
• Feeling weak.
• Blood tests show a decrease in the number of red blood cells or platelets or the amount of hemoglobin.

Very Rare(may affect up to 1 in 10,000 patients)

• Being more sensitive to the sun than usual.

Other Adverse Effects Reported:

Tell your doctor if any of the following conditions worsen or last more than a few days.

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very few blood cells.
• Blood tests show lower than normal sodium levels.
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers on your hands and feet change color when cold and feel tingling or pain when warming up (Raynaud's phenomenon).
• Chest enlargement in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ramipril Normon

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ramipril Normon

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other ingredients are: microcrystalline cellulose, pregelatinized cornstarch, low-substitution hydroxypropylcellulose, red iron oxide (E-172), sodium hydrogen carbonate, and magnesium stearate.

Appearance of the Product and Packaging Content

Pink, round, biconvex, and scored tablets.

They are presented in packages containing blisters with 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus:July 2024

This prospectus does not contain all the information about your medicine. If you have any questions or are unsure about something, ask your doctor or pharmacist.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/68276/P_68276.html